[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598119":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":31,"responsibleParty":54,"collaborators":20,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":20,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":20,"enrollmentInfo":66,"targetDuration":20,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Sichuan University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation","EXPERIMENTAL","Study drug IR-101 Dose Escalation",[13],"Drug: IR-101",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","IR-101","IR-101 Dose Escalation",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Rong Tian, MD","West China Hospital","PRINCIPAL_INVESTIGATOR",[27],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","18980601586","rongtiannuclear@126.com",[32,47],{"facility":24,"status":33,"city":34,"state":35,"zip":20,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Chengdu","Sichuang","China","CN",{"type":39,"coordinates":40},"Point",[41,42],104.06667,30.66667,{"lat":42,"lon":41},[45],{"name":46,"role":28,"phone":20,"phoneExt":20,"email":20},"Xiaoai Wu, Phd",{"facility":24,"status":33,"city":34,"state":20,"zip":20,"country":36,"countryCode":37,"cosmosGeoPoint":48,"geoPoint":50,"contacts":51},{"type":39,"coordinates":49},[41,42],{"lat":42,"lon":41},[52],{"name":53,"role":28,"phone":20,"phoneExt":20,"email":20},"Xiaoai Wu",{"type":25,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Rong Tian","Director","100598119","early-phase-1-safety--efficacy-of-ir-101-in-relapsedrefractory-neuroblastoma-100598119",false,"NCT07067346","Safety & Efficacy of IR-101 in Relapsed\u002FRefractory Neuroblastoma","A Study to Evaluate Safety and Efficacy of Radiopharmaceutical IR-101 in Patients With Relapsed or Refractory Neuroblastoma","Inclusion Criteria:\n\n1. Relapsed or refractory high-risk neuroblastoma with MIBG avid lesions in accordance with the Revised International Neuroblastoma Response Criteria (INRC);\n2. All soft-tissue lesions detected on CT\u002FMRI must be MIBG-avid;\n3. Age ≥12 months;\n4. Lansky performance status ≥50%;\n5. Adequate organ function and hematologic parameters;\n\nExclusion Criteria:\n\n1. Antibody-based immunotherapy within 5 half-lives or 30 days (whichever is shorter), or not yet recovered from adverse reactions of prior biologic therapies；\n2. Treatment with \\[¹³¹I\\]MIBG or Lu-177 targeted radionuclide therapy \\\u003C3 months of last administration;\n3. Autologous transplant \\\u003C12 weeks, or Allogeneic transplant \\\u003C4 months (patients \\>4 months post-transplant must be free of active GVHD);\n4. Radiotherapy within 2 weeks prior to first dose of study drug (However, if the subjects undergone radiotherapy for the sole lesion have MIBG uptake after 2 weeks of radiotherapy completion, they will be eligible); or Extensive-field radiotherapy (e.g., Cranio-spinal cord, whole lung, whole abdomen, or \\>50% bone marrow) within 12 weeks prior to first dose of study drug;\n5. Renal Insufficiency;\n6. Active Infections;","ALL","12 Months",{"count":67,"type":68},10,"ESTIMATED","INTERVENTIONAL",[71],"EARLY_PHASE1","Radiopharmaceutical in Relapsed\u002FRefractory Neuroblastoma",[74],"Neuroblastoma",[76],"Radiopharmaceutical","2025-07-27",{"date":79,"type":80},"2025-07-29","ACTUAL",{"date":82,"type":80},"2025-07-18",{"date":84,"type":68},"2026-06-30",{"name":5,"class":6},2]